UNITED STATES DISTRICT COURT MICHAEL LANE, Plaintiff ......Feb 28, 2020 · of individuals to treat...

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UNITED STATES DISTRICT COURT

DISTRICT OF RHODE ISLAND

MICHAEL LANE,

Plaintiff,

v.

BOEHRINGER INGELHEIM

PHARMACEUTICALS, INC., SANOFI

US SERVICES INC., CHATTEM, INC.,

PFIZER, INC., AND

GLAXOSMITHKLINE, LLC

Defendants.

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CIVIL ACTION NO.: COMPLAINT AND JURY DEMAND

COMPLAINT AND JURY DEMAND

COMES NOW, Michael Lane, by and through undersigned counsel, and files this

Complaint against Defendants Boehringer Ingelheim Pharmaceuticals, Inc., Sanofi US Services

Inc., Chattem, Inc., Pfizer, Inc., and GlaxoSmithKline, LLC, (hereinafter collectively referred to

as “Defendants”) for personal injuries suffered as a result of Mr. Lane’s use of Defendants’

Zantac/ranitidine, which were manufactured, formulated, tested, packaged, labeled, produced,

created, made, constructed, assembled, marketed, advertised, promoted, distributed, and sold by

Defendants.

I. INTRODUCTION

1. Zantac, the brand name version of the chemical ranitidine, (generics and name

brand Zantac are herein collectively referred to as “Zantac”) prior to its recall, was used by millions

of individuals to treat gastrointestinal conditions like acid indigestion, heartburn, sour stomach,

and gastroesophageal reflux disease. Sales of Zantac in the United States since its introduction in

1983 have reached over $1 billion.

2. Zantac contains N-Nitrosodimethylamine (“NDMA”), a chemical recognized as a

potent carcinogen. Formerly a chemical biproduct of making rocket fuel in the early 1900s, the

Case 1:20-cv-00099 Document 1 Filed 02/28/20 of 40 PageID #: 1

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dangers of NDMA have been publicly known for over 40 years. Both the World Health

Organization and the Environmental Protection Agency recognize NDMA as carcinogenic.

3. Zantac, as well as generic bioequivalent formulations of ranitidine, were available

in both prescription and over-the-counter form. When used as prescribed or recommended, Zantac

leads to the production of staggering amounts of NDMA when digested by the human body. The

U. S. Food and Drug Administration’s (“FDA”) allowable daily limit of NDMA is 96 ng

(nanograms) and yet, in a single dose of Zantac, researchers are discovering over 3 million ng.

4. Recent discoveries of these dangerous findings spurred widespread recalls of

Zantac by numerous manufacturers both domestically and internationally. The current owner and

controller of the Zantac new drug applications (“NDAs”) has recalled all Zantac in the United

States. FDA is actively investigating the issue, with its preliminary results showing “unacceptable”

levels of NDMA within the products. The presence of NDMA in Zantac is not due to

contamination or manufacturing error, but a function of the ranitidine molecule and the way it

breaks down in the human digestive system.

5. Plaintiff Michael Lane took Zantac for approximately five years and, as a result,

developed bladder cancer. His cancer was caused by NDMA exposure created by the ingestion of

Zantac. This lawsuit seeks damages against the Defendants for causing Mr. Lane to develop

cancer.

II. PARTIES

6. Plaintiff Michael Lane (hereinafter “Plaintiff”) resides in Providence County,

Rhode Island and is a citizen of Rhode Island and not of any other state.

7. Defendant Boehringer Ingelheim Pharmaceuticals, Inc. (“BI”) is a Delaware

corporation with its principal place of business located at 900 Ridgebury Road, Ridgefield,

Connecticut 06877. BI is a citizen of Connecticut and Delaware and not of any other state. BI is a

subsidiary of the German company Boehringer Ingelheim Corporation. BI owned and controlled

the NDA for over-the counter (“OTC”) Zantac between approximately October 2006 and January

2017 and manufactured and distributed the drug in the United States during that period.

8. Defendant Sanofi US Services Inc. (“Sanofi”) is a Delaware corporation with its

principal place of business located at 55 Corporate Drive, Bridgewater, New Jersey 08807 and is

a wholly owned subsidiary of Sanofi S.A. Sanofi is a citizen of Delaware and New Jersey and is

not a citizen of any other state. Sanofi controlled the NDA for OTC Zantac starting In January


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2017 through the present and manufactured and distributed the drug in the United States during

that period. Sanofi voluntarily recalled all brand name OTC Zantac on October 18, 2019.

9. Defendant Chattem, Inc. (“Chattem”) is a Tennessee corporation with its principal

place of business located at 1715 West 38th Street, Chattanooga, Tennessee 37409. Chattem is a

citizen of Tennessee and not a citizen of any other state. Chattem is a wholly owned subsidiary of

Sanofi S.A., a French multinational corporation. Chattem distributed OTC Zantac for Sanofi

throughout the United States until Sanofi’s voluntary recall.

10. Defendant Pfizer, Inc. (“Pfizer”) is a Delaware corporation with its principal place

of business located at 235 East 42nd Street, New York, New York 10017. Pfizer is a citizen of

Delaware and New York and is not a citizen of any other state. In 1993, Glaxo Wellcome, PLC

formed a joint venture with Warner-Lambert,Inc. to develop and obtain OTC approval for Zantac.

That OTC approval was obtained in 1995. In 1997, Warner-Lambert and Glaxo Wellcome ended

their joint venture with Warner-Lambert retaining control over the OTC NDA for Zantac and the

Zantac trademark in the U.S. and Glaxo Wellcome retaining control over the Zantac trademark

internationally. In 2000, Warner-Lambert was acquired by Pfizer who maintained control over the

Zantac OTC NDA until December 2006.

11. Defendant GlaxoSmithKline, LLC (“GSK”) is a Delaware company with its

principal place of business located at 5 Crescent Drive, Philadelphia, Pennsylvania 19112 and Five

Moore Drive, Research Triangle, North Carolina 27709. GSK is a wholly owned subsidiary of

GlaxoSmithKline, PLC, which is its sole member. GlaxoSmithKline, PLC is a citizen of the United

Kingdom and is not a citizen of any state in the United States. GlaxoSmithKline, PLC is the

successor-in-interest to the companies that initially developed, patented, and commercialized the

molecule known as ranitidine. Ranitidine was initially developed by Allen & Hansburys Ltd.

which was a subsidiary of Glaxo Labs Ltd. Allen & Hansburys Ltd. was awarded Patent No.

4,128,658 by the U.S. Patent and Trademark Office in December 1978, which covered the

ranitidine molecule. In 1983, Glaxo Holdings Ltd. was awarded approval by the U.S. FDA to sell

Zantac in the United States. Glaxo Holdings, Ltd. was later absorbed into Glaxo Wellcome, PLC.

And then, in 2000, GlaxoSmithKline, PLC and GSK were created by the merger of Glaxo

Wellcome and SmithKline Beechum. GSK, and its predecessors, controlled the prescription

Zantac NDA between 1983 and 2009.Under Florida law, GSK is the innovator of Zantac and


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through its negligence and willful misconduct caused the labeling on the OTC Zantac label to not

include any warning for cancer.

III. JURISDICTION AND VENUE

12. This Court has subject matter jurisdiction pursuant to 28 U.S.C.§ 1332. There is

complete diversity of citizenship between the parties. In addition, Plaintiff seeks damages in excess

of $75,000, exclusive of interest and costs.

13. This Court has personal jurisdiction over each Defendant insofar as each Defendant

is authorized and licensed to conduct business in the State of Rhode Island, maintains and carries

on systematic and continuous contacts in this judicial district, regularly transacts business within

this judicial district, and regularly avails itself of the benefits of this judicial district.

14. Additionally, the Defendants caused tortious injury by acts and omissions in this

judicial district and caused tortious injury in this district by acts and omissions outside this district

while regularly doing and soliciting business, engaging in a persistent course of conduct, and

deriving substantial revenue from goods used or consumed and services rendered in this judicial

district.

15. Venue is proper before this Court pursuant to 28 U.S.C. § 1391 because a

substantial part of the events or omissions giving rise to this claim occurred within this judicial

district.

IV. HISTORY OF ZANTAC AND RANITIDINE

16. Zantac was developed by Glaxo – now GlaxoSmithKline (“GSK”) – and approved

for prescription use by the FDA in 1983. The drug belongs to a class of medications called

histamine H2-receptor antagonists (or H2 blockers) which decrease the amount of acid produced

by the stomach and are used to treat gastric ulcers, heartburn, acid indigestion, sour stomach, and

other gastrointestinal conditions. Ranitidine was specifically developed by Glaxo in response to

the then leading H2 blocker, cimetidine (Tagamet).

17. At the time that ranitidine was developed, there was scientific literature suggesting

that drugs like ranitidine, which contain a dimethylamine (“DMA”) group within the molecule,

were highly likely to form the NDMA when combined with other substances, i.e nitrite, already

found in the body. Indeed, nitrite is not only naturally found in the body, but bacteria and enzymes

in the body, reduce the nitrates (NO3) found in food into nitrites (NO-2) and many foods and


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preservatives contain nitrates. GSK scientists knew or should have known that human physiology

and diet would lead to the development of NDMA in the human body after ingestion of ranitidine.

18. Due in large part to GSK’s marketing strategy, Zantac was a wildly successful drug

reaching $1 billion in total sales in December 1986. As one 1996 article put it, Zantac became the

“ the best-selling drug in history as a result of a shrewd, multifaceted marketing strategy that . . .

enabled the product to dominate the acid/peptic marketplace.” 1 Significantly, the marketing

strategy that led to Zantac’s success emphasized the purported safety of the drug.

19. Zantac became available without a prescription in 1996 and generic versions of the

drug (ranitidine) became available the following year. Zantac sales have remained strong over

time. As recently as 2018, Zantac was one of the top ten antacid tablet brands in the United States

with sales of Zantac 150 totaling $128.9 million.

20. On September 13, 2019, in response to a citizen’s petition filed by Valisure, Inc.

(discussed in detail below), U.S. and European regulators stated that they are reviewing the safety

of ranitidine.

21. On September 18, 2019, Novartis AG’s Sandoz Unit, which makes generic drugs,

stated that it was halting the distribution of its versions of Zantac in all markets while Canada

requested drug makers selling ranitidine to stop distribution.

22. On September 28, 2019, CVS Health Corp. stated that it would stop selling Zantac

and its own generic ranitidine products out of concern that it might contain a carcinogen. CVS has

been followed by Walmart, Inc., Walgreens Boot Alliance, and Rite Aid Corp. to also remove

Zantac and ranitidine products.

23. On October 2, 2019, the FDA stated that it was ordering all manufacturers of Zantac

and ranitidine products to conduct testing for NDMA and that preliminary results indicated

unacceptable levels of NDMA so far.

24. On November 1, 2019, the FDA released its preliminary results showing unsafe

levels of NDMA in various ranitidine products including the brand name products controlled by

Sanofi.

1 Wright, R., How Zantac Became the Best-Selling Drug in History, 1 J. HEALTHCARE

MARKETING 4, 24 (Winter 1996).


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25. Since November 2019, multiple manufacturers of ranitidine products have issued

voluntary recalls due to findings of elevated NDMA in their product.

26. Prior to the recalls, and even in conjunction with the recalls, at no time did any

Defendant attempt to include a warning about NDMA or any cancer nor did the FDA ever reject

such a warning. Defendants had the ability to unilaterally add an NDMA and/or cancer warning to

the Zantac label (for both prescription and OTC) without prior FDA approval pursuant to the

mechanisms within the regulatory standards. Had any Defendant attempted to add a NDMA

warning to the Zantac label (either for prescription or OTC) the FDA would not have rejected it.

V. DANGERS OF NDMA

27. According to the Environmental Protection Agency’s Technical Fact Sheet, NDMA

is a semi-volatile organic chemical that forms in both industrial and natural processes. It is a

member of N-nitrosamines, a family of potent carcinogens. The dangers that NDMA poses to

human health have long been recognized. A news article published in 1979 noted that “NDMA

has caused cancer in nearly every laboratory animal tested so far.”2 NDMA is no longer produced

or commercially used in the United States, except for research, such as a tumor initiator in certain

animal bioassays. In other words, it is only a poison.

28. Both the environmental Protection Agency (“EPA”) and the International Agency

for Research on Cancer (“IARC”) have classified NDMA as a probable human carcinogen. The

World Health Organization (“WHO”) has stated that scientific testing indicates that NDMA

consumption is positively associated with either gastric or colorectal cancer and suggests that

humans may be especially sensitive to the carcinogenicity of NDMA.

29. As early as 1980, consumer products containing unsafe levels of NDMA and other

nitrosamines have been recalled by manufacturers either voluntarily or at the direction of the FDA.

30. Most recently, beginning in the summer of 2018, there have been recalls of several

generic drugs used to treat high blood pressure and heart failure – Valsartan, Losartan, and

2 Jane Brody, Bottoms Up: Alcohol in moderation can extend life, THE GLOBE AND MAIL (CANADA)

(Oct. 11, 1979); see Rudy Platiel, Anger grows as officials unable to trace poison in reserve’s water, THE

GLOBE AND MAIL CANADA) (Jan. 6, 1990) (reporting that residents of Six Nations Indian Reserve

“have been advised not to drink, cook or wash in the water because testing has found high levels of N-

nitrosodimethylamine (NDMA), an industrial byproduct chemical that has been linked to cancer”);

Kyrtopoulos et al, DNA adducts in humans after exposure to methylating agents, 405 MUTAT. RESEAR.

135 (1998) (noting that “chronic exposure of rats to very low doses of NDMA gives rise predominantly to

liver tumours, including tumors of the liver cells (hepatocellular carcinomas), bile ducts, blood vessels and

Kupffer cells”).


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Irbesartan – because the medications contained nitrosamine impurities that do no meet the FDA’s

safety standards. The FDA has established a permissible daily intake limit for the probable human

carcinogen, NDMA, of 96 ng (nanogram). However, the highest level of NDMA detected by the

FDA in any of the Valsartan tablets was 20.19 μg (or 20,190 ng) per tablet. In the case of Valsartan,

the NDMA was an impurity caused by a manufacturing defect, and thus NDMA was present in

only some products containing Valsartan. Based on the amount of NDMA in a single Zantac tablet,

Zantac poses a greater safety risk 124 times greater than any of the recently recalled Valsartan

tablets. Not only is NDMA a byproduct of the ranitidine molecule, itself, but the levels observed

in recent testing show NDMA levels in excess of 3,000,000 ng.

31. In mouse studies examining the carcinogenicity of NDMA through oral

administration, animals exposed to NDMA developed cancer in the kidney, bladder, liver,

and lung. In comparable rat studies, similar cancers were observed in the liver, kidney,

pancreas, and lung. In comparable hamster studies, similar cancers were observed in the

liver, pancreas, and stomach. In comparable Guinea-pig studies, similar cancers were

observed in the liver and lung. In comparable rabbit studies, similar cancers were observed

in the liver and lung.

32. In other long-term animal studies in mice and rats utilizing different routes of

exposures—inhalation, subcutaneous injection, and intraperitoneal (abdomen injection)—

cancer was observed in the lung, liver, kidney, nasal cavity, and stomach.

33. Alarmingly, Zantac is in the FDA’s category B for birth defects, meaning it is

considered safe to take during pregnancy. However, in animal experiments, for those animals

exposed to NDMA during pregnancy, the offspring had elevated rates of cancer in the liver and

kidneys.

34. In addition, NDMA breaks down into various derivative molecules that,

themselves, are associated with causing cancer. In animal studies, derivatives of NDMA

induced cancer in the stomach and intestine (including colon).

35. Research shows that lower levels of NDMA, i.e., 40 ng, are fully

metabolized in the liver, but high doses enter the body’s general circulation.

36. Numerous in vitro studies confirm that NDMA is a mutagen—causing

mutations in human and animal cells.


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37. Overall the animal data demonstrates that NDMA is carcinogenic in all animal

species tested: mice, rats, Syrian golden, Chinese and European hamsters, guinea-pigs,

rabbits, ducks, mastomys, fish, newts, and frogs.

38. Pursuant to the EPA cancer guidelines, “tumors observed in animals are

generally assumed to indicate that an agent may produce tumors in humans.”3

39. In addition to the overwhelming animal data linking NDMA to cancer, there are

numerous human epidemiological studies exploring the effects of dietary exposure to various

cancers. And, while these studies (several discussed below) consistently show increased risks

of various cancers, the exposure levels considered in these studies are a very small fraction—as

little as 1 millionth—the exposures noted in a single Zantac capsule, i.e., 0.191 ng/day (dietary)

v. 304,500 ng/day (Zantac).

40. In a 1995 epidemiological case-control study looking at NDMA dietary

exposure with 220 cases, researchers observed a statistically significant 700% increased risk

of gastric cancer in persons exposed to more than 0.51 ng/day.4 In a similar study looking at

NDMA dietary exposure with 746 cases, researchers observed statistically significant elevated

rates of gastric cancer in persons exposed to more than 0.191 ng/day.5

41. In another 1995 epidemiological case-control study looking at, in part, the

effects of dietary consumption on cancer, researchers observed a statistically significant

elevated risk of developing aerodigestive cancer after being exposed to NDMA at .179 ng/day.6

42. In a 1999 epidemiological cohort study looking at NDMA dietary exposure with

189 cases and a follow up of 24 years, researchers noted that “N-nitroso compounds are potent

carcinogens” and that dietary exposure to NDMA more than doubled the risk of developing

colorectal cancer.7

3 See https://www3.epa.gov/airtoxics/cancer guidelines final 3-25-05.pdf. 4 Pobel, et al., Nitrosamine, nitrate and nitrite in relation to gastric cancer: a case-control study in

Marseille, France, 11 EUROP. J. EPIDEMIOL. 67–73 (1995). 5 La Vecchia, et al., Nitrosamine intake and gastric cancer risk, 4 EUROP. J. CANCER. PREV. 469–474

(1995).

6 Rogers, et al., Consumption of nitrate, nitrite, and nitrosodimethylamine and the risk of upper

aerodigestive tract cancer, 5 CANCER EPIDEMIOL. BIOMARKERS PREV. 29–36 (1995).

7 Knekt, et al., Risk of Colorectal and Other Gastro-Intestinal Cancers after Exposure to Nitrate, Nitrite

and N-nitroso Compounds: A Follow-Up Study, 80 INT. J. CANCER 852–856 (1999)


https://www3.epa.gov/airtoxics/cancer_guidelines_final_3-25-05.pdf

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43. In a 2000 epidemiological cohort study looking at occupational exposure of

workers in the rubber industry, researchers observed significant increased risks for NDMA

exposure for esophagus, oral cavity, pharynx, prostate, and brain cancer.8

44. In a 2011 epidemiological cohort study looking at NDMA dietary exposure

with 3,268 cases and a follow up of 11.4 years, researchers concluded that “[d]ietary NDMA

intake was significantly associated with increased cancer risk in men and women” for all

cancers, and that “NDMA was associated with increased risk of gastrointestinal cancers”

including rectal cancers.9

45. In a 2014 epidemiological case-control study looking at NDMA dietary

exposure with 2,481 cases, researchers found a statistically significant elevated association

between NDMA exposure and colorectal cancer.10

VI. HOW RANITIDINE TRANSFORMS INTO NDMA WITHIN THE BODY

46. The high levels of NDMA produced by Zantac are not caused by a

manufacturing defect but are inherent to the molecular structure of ranitidine, the active

ingredient in Zantac. The ranitidine molecule contains both a nitrite and DMA group which

are well known to combine to form NDMA. See Fig. 1. Thus, ranitidine produces NDMA by

“react[ing] with itself,” which means that every dosage and form of ranitidine, including

Zantac, exposes users to NDMA.

8 Straif, et al., Exposure to high concentrations of nitrosamines and cancer mortalityamong a cohort of

rubber workers, 57 OCCUP ENVIRON MED 180–187 (2000).

9 Loh, et al., N-nitroso compounds and cancer incidence: the European Prospective Investigation

into Cancer and Nutrition (EPIC)–Norfolk Study, 93 AM J CLIN NUTR. 1053–61 (2011).

10 Zhu, et al., Dietary N-nitroso compounds and risk of colorectal cancer: a case-control study in

Newfoundland and Labrador and Ontario, Canada, 111 BR J NUTR. 6, 1109–1117 (2014).


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Figure 1 – Ranitidine Structure & Formation of NDMA

47. The formation of NDMA by the reaction of DMA and a nitroso source (such as

a nitrite) is well characterized in the scientific literature and has been identified as a concern

for contamination of the American water supply.11 Indeed, in 2003, alarming levels of NDMA

in drinking water processed by wastewater treatment plants was specifically linked to the

presence of ranitidine.12

48. In 1981, the very year Zantac was launched commercially outside of the US, two

exchanges in The Lancet—one of the most widely read and respected medical and scientific

publications—discussed the potential toxicity of cimetidine and ranitidine. Cimetidine, also an

H2 blocker, has a similar chemical structure to ranitidine.

49. Dr. Silvio de Flora, an Italian researcher from the University of Genoa, wrote about

experiments he had conducted looking at cimetidine and ranitidine in human gastric fluid. When

ranitidine was exposed to gastric fluid in combination with nitrites, his experiment showed “toxic

and mutagenic effects[.]”13 Dr. de Flora hypothesized that these effects could have been caused by

the “formation of more than one nitroso derivative [which includes NDMA] under our

11 Ogawa, et al., Purification and properties of a new enzyme, NG, NG-dimethylarginine

dimethylaminohydrolase, from rat kidney, 264 J. BIO. CHEM. 17, 10205-10209 (1989). 12 Mitch, et al., N-Nitrosodimethylamine (NDMA) as a Drinking Water Contaminant: A Review, 20

ENV. ENG. SCI. 5, 389-404 (2003). 13 De Flora, Cimetidine, Ranitidine and Their Mutagenic Nitroso Derivatives, THE LANCET 993-994

(Oct. 31, 1981).


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experimental conditions.” Concerned with these results, Dr. de Flora cautioned that, in the context

of ranitidine ingestion, “it would seem prudent to avoid nitrosation as far as possible by, for

example, suggesting a diet low in nitrates and nitrites, by asking patients not to take these at times

close to (or with) meals, or by giving inhibitors of nitrosation such as ascorbid acid.”

50. GSL responded to Dr. de Flora’s concern.14 A group of GSK researchers specifically

noted they “were obviously concerned as to whether or not a mutagenic N-nitroso derivative of

ranitidine could be formed in the stomach.” GSK was fully aware of the potential NDMA issue,

and acknowledged that when ranitidine was in the presence of nitrites, a “N-nitroso nitrolic acid

derivative was formed” that was “mutagenic[.]” GSK, however, dismissed this finding because the

levels of nitrate used were much higher than what would be expected to occur after a meal and,

therefore, any N-Nitroso compound found would not likely occur in human in real world

experiences. GSK asserted that “no mutagenic nitrosated product of ranitidine is likely to be

formed in man under any conceivable physiological conditions[.]”

51. In 1983, the same year Zantac was approved in the U.S., seven researchers from the

University of Genoa published a study discussing the nitrosation of ranitidine and its genotoxic

effects (ability to harm DNA).15 The researchers concluded “it appears that reaction of ranitidine

with excess sodium nitrite under acid conditions gives rise to a nitroso-derivative (or derivatives)

[like NDMA] capable of inducing DNA damage in mammalian cells. ... These findings are consistent

with those of De Flora, who showed that preincubation of ranitidine with excess nitrite in human

gastric juice resulted in mutagenic effects[.]”

52. Then, again in 1983, Dr. de Flora, along with four other researchers, published the

complete findings.16 The results “confirm our preliminary findings on the formation of genotoxic

derivatives from nitrite and ranitidine[.]” Id. Again, the authors noted that, “ the widespread clinical

use [of ranitidine] and the possibility of a long-term maintenance therapy suggest the prudent

adoption of some simple measures, such as a diet low in nitrates and nitrites or the prescription of

these anti-ulcer drugs at a suitable interval from meals . . .Ascorbic acid has been proposed as an

inhibitor of nitrosation combined with notrosatiable drugs and appears to block efficiently the

formation of mutagenic derivatives from . . . ranitidine.” Id.

14 Brittain, et al., The Safety of Ranitidine, THE LANCET 1119 (Nov. 14, 1981). 15 Maura, et al., DNA Damage Induced by Nitrosated Ranitidine in Cultured Mammalian Cells, 18 TOX.

LTTRS. 97-102 (1983). 16 De Flora, et al., Genotoxicity of nitrosated ranitidine, 4 CARCINOGENESIS 3, 255-260 (1983).


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53. The high instability of the ranitidine molecule was elucidated in scientific studies

investigating ranitidine as a source of NDMA in drinking water and specific mechanisms for

the breakdown of ranitidine were proposed.17 These studies underscore the instability of the

NDMA group on the ranitidine molecule and its ability to form NDMA in the environment of

water treatment plants which supply many American cities with water.

54. These studies did not appreciate the full extent of NDMA formation risk from

ranitidine; specifically, the added danger of this drug having not only a labile DMA group but

also a readily available nitroso source in its nitrite group on the opposite terminus of the

molecule. Recent testing of NDMA levels in ranitidine batches are so high that the nitroso for

NDMA likely comes from no other source than the ranitidine molecule itself.

55. Valisure, LLC is an online pharmacy that also runs an analytical laboratory that

is ISO 17025 accredited by the International Organization for Standardization (“ISO”) – an

accreditation recognizing the laboratories technical competence for regulatory. Valisure’s

mission is to help ensure the safety, quality, and consistency of medications and supplements

in the market. In response to rising concerns about counterfeit medications, generics, and

overseas manufacturing, Valisure developed proprietary analytical technologies that it uses in

addition to FDA standard assays to test every batch of every medication it dispenses.

56. As part of its testing of Zantac, and other ranitidine products, in every lot tested,

Valisure discovered exceedingly high levels of NDMA. Valisure’s ISO 17025 accredited

laboratory used FDA recommended GC/MS headspace analysis method FY19-005-DPA8 for the

determination of NDMA levels. As per the FDA protocol, this method was validated to a lower

limit of detection of 25 ng.18 The results of Valisure’s testing show levels of NDMA well above 2

million ng per 150 mg Zantac tablet, shown below in Table 1.

17 Le Roux, et al., NDMA Formation by Chloramination of Ranitidine: Kinetics and Mechanism, 46

Environ. Sci. Technol. 20, 11095-11103 (2012).

18 US Food and Drug Administration. (updated 01/25/2019). Combined N-

Nitrosodimethlyamine (NDMA) and N-Nitrosodiethylamine (NDEA) Impurity Assay, FY19-

005-DPA-S.


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Table 1 – Ranitidine Samples Tested by Valisure Laboratory Using GC/MS Protocol

150 mg Tablets or equivalent Lot # NDMA per tablet (ng)

Reference Powder* 125619 2,472,531

Zantac, Brand OTC 18M498M 2,511,469

Zantac (mint), Brand OTC 18H546 2,834,798

Wal-Zan, Walgreens 79L800819A 2,444,046

Wal-Zan (mint), Walgreens 8ME2640 2,635,006

Ranitidine, CVS 9BE2773 2,520,311

Zantac (mint), CVS 9AE2864 3,267,968

Ranitidine, Equate 9BE2772 2,479,872

Ranitidine (mint), Equate 8ME2642 2,805,259

Ranitidine, Strides 77024060A 2,951,649

57. Valisure’s testing shows, on average, 2,692,291 ng of NDMA in a 150 mg Zantac

tablet. Considering the FDA’s permissible limit is 96 ng, this would put the level of NDMA at

28,000 times the legal limit. In terms of smoking, a person would need to smoke at least 6,200

cigarettes to achieve the same levels of NDMA found in one 150 mg dose of Zantac.

58. Valisure, however, was concerned that the extremely high levels of NDMA

observed in its testing were a product of the modest oven heating parameter of 130 °C in the

FDA recommended GC/MS protocol. So, Valisure developed a low temperature GC/MS method

that could still detect NDMA but would only subject samples to 37 °C, the average temperature

of the human body. This method was validated to a lower limit of detection of 100 ng.

59. Valisure tested ranitidine tablets by themselves and in conditions simulating the

human stomach. Industry standard “Simulated Gastric Fluid” (“SGF” 50 mM potassium chloride,

85 mM hydrochloric acid adjusted to pH 1.2 with 1.25 g pepsin per liter) and “Simulated Intestinal

Fluid” (“SIF” 50 mM potassium chloride, 50 mM potassium phosphate monobasic adjusted to pH

6.8 with hydrochloric acid and sodium hydroxide) were used alone and in combination with

various concentrations of nitrite, which is commonly ingested in foods like processed meats and

is elevated in the stomach by antacid drugs.


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60. Indeed, Zantac was specifically advertised to be used when consuming foods

containing high levels of nitrates, like tacos, pizza, etc.19

61. The results of Valisure’s tests on ranitidine tablets in biologically relevant

conditions demonstrate significant NDMA formation under simulated gastric conditions with

nitrite present (see Table 2).

Table 2 – Valisure Biologically relevant tests for NDMA formation

Ranitidine Tablet Studies NDMA (ng/mL) NDMA per tablet (ng)

Tablet without Solvent Not Detected Not Detected

Tablet Not Detected Not Detected

Simulated Gastric Fluid (“SGF”) Not Detected Not Detected

Simulated Intestinal Fluid Not Detected Not Detected

SGF with 10 mM Sodium Nitrite Not Detected Not Detected

SGF with 25 mM Sodium Nitrite 236 23,600

SGF with 50 mM Sodium Nitrite 3,045 304,500

62. Under biologically relevant conditions, when nitrites are present, staggeringly high

levels of NDMA are found in one dose of 150 mg Zantac, ranging between 245 and 3,100 times

above the FDA-allowable limit. By comparison, as NDMA is found in cigarettes, one would need

to smoke over 500 cigarettes to achieve the same levels of NDMA found in one dose of 150 mg

Zantac at the 25 ng level (over 7,000 for the 50 μg level).

63. Antacid drugs are known to increase stomach pH and thereby increase the growth

of nitrite-reducing bacteria which further elevate levels of nitrite. This fact is well known and even

present in the warning labels of antacids like Prevacid (lansoprazole) and was specifically studied

19 See, e.g., https://www.ispot.tv/ad/dY7n/zantac-family-taco-night;

https://youtu.be/jzS2kuB5_wg; https://youtu.be/Z3QMwkSUlEg;

https://youtu.be/qvh9gyWqQns.


https://www.ispot.tv/ad/dY7n/zantac-family-taco-night

https://youtu.be/jzS2kuB5_wg



https://youtu.be/Z3QMwkSUlEg

https://youtu.be/qvh9gyWqQns

15

with ranitidine in the original approval of the drug. Thus, higher levels of nitrites in patients

regularly taking Zantac would be expected.

64. In fact, NDMA formation in the stomach has been a concern for many years and

specifically ranitidine has been implicated as a cause of NDMA formation by multiple research

groups, including those at Stanford University.

65. Existing research shows that ranitidine interacts with nitrites and acids in the

chemical environment of the human stomach to form NDMA. In vitro tests demonstrate that when

ranitidine undergoes “nitrosation” (the process of a compound being converted into nitroso

derivatives) by interacting with gastric fluids in the human stomach, the by-product created is

DMA – which is an amine present in ranitidine itself. When DMA is released, it can be nitrosated

even further to form NDMA, a secondary N-nitrosamine.

66. Moreover, in addition to the gastric fluid mechanisms investigated in the scientific

literature, Valisure identified a possible enzymatic mechanism for the liberation of ranitidine’s

DMA group via the human enzyme dimethylarginine dimethylaminohydrolase (“DDAH”),

which can occur in other tissues and organs separate from the stomach. 69. Liberated

DMA can lead to the formation of NDMA when exposed to nitrite present on the ranitidine

molecule, nitrite freely circulating in the body, or other potential pathways, particularly in weak

acidic conditions such as that in the kidney or bladder. The original scientific paper detailing the

discovery of the DDAH enzyme in 1989 specifically comments on the propensity of DMA to form

NDMA: “This report also provides a useful knowledge for an understanding of the endogenous

source of dimethylamine as a precursor of a potent carcinogen, dimethylnitrosamine [NDMA].”20

67. In Figure 2, below, computational modelling demonstrates that ranitidine (shown in

green) can readily bind to the DDAH-1 enzyme (shown as a cross-section in grey) in a manner

20 Ogawa, et al., Purification and properties of a new enzyme, NG, NG-dimethylarginine

dimethylaminohydrolase, from rat kidney, 264 J. BIO. CHEM. 17, 10205-10209 (1989).


16

similar to the natural substrate of DDAH-1 known as asymmetric dimethylarginine (“ADMA,”

shown in blue).

Figure 2 – Computational Modelling of Ranitidine Binding to DDAH-1 Enzyme

68. These results indicate that the enzyme DDAH-1 increases formation of NDMA in

the human body when ranitidine is present; therefore, the expression of the DDAH-1 gene is useful

for identifying organs most susceptible to this action.

69. Figure 3 below, derived from the National Center for Biotechnology Information,

illustrates the expression of the DDAH-1 gene in various tissues in the human body.


17

Figure 3 – Expression Levels of DDAH-1 Enzyme by Organ

70. DDAH-1 is most strongly expressed in the kidneys but also broadly distributed

throughout the body, such as in the liver, prostate, stomach, bladder, brain, colon, and prostate.

This offers both a general mechanism for NDMA formation in the human body from ranitidine

and specifically raises concern for the effects of NDMA on numerous organs, including the

bladder.

71. In addition to the aforementioned in vitro studies that suggest a strong connection

between ranitidine and NDMA formation, in vivo clinical studies in living animals add further weight

to concern over this action and overall potential carcinogenicity. A study published in the journal

Carcinogenesis in 1983 titled “Genotoxic effects in rodents given high oral doses of ranitidine and

sodium nitrite” specifically suspected the carcinogenic nature of ranitidine in combination with

nitrite. The authors of this study concluded: “Our experimental findings have shown that

simultaneous oral administration in rats of high doses of ranitidine and NaNO2 [nitrite] can produce

DNA fragmentation either in liver or in gastric mucosa. 21

21 Brambilla, et al., Genotoxic effects in rodents given high oral doses of ranitidine and sodium nitrite, 4

CARCINOGENESIS 10, 1281-1285 (1983).


18

72. The human data, although limited at this point, is even more concerning. A study

completed and published in 2016 by Stanford University observed that healthy individuals, both

male and female, who ingested Zantac 150 mg tablets produced roughly 400 times elevated

amounts of NDMA in their urine (over 47,000 ng) in the proceeding 24 hours after ingestion.22

73. Likely due to the perceived high safety profile of ranitidine, very few

epidemiological studies have been conducted on this drug.

74. A 2004 study published by the National Cancer Institute investigated 414 cases of

peptic ulcer disease reported in 1986 and followed the individual cases for 14 years.23 One of the

variables investigated by the authors was the patients’ consumption of a prescription antacid, either

Tagamet (cimetidine) or Zantac (ranitidine). The authors concluded that “[r]ecent use of ulcer

treatment medication (Tagamet and Zantac) was also related to the risk of bladder cancer, and this

association was independent of the elevated risk observed with gastric ulcers.” Specifically, the

authors note that “N-Nitrosamines are known carcinogens, and nitrate ingestion has been related

to bladder cancer risk.” NDMA is among the most common of the N-Nitrosamines.

75. A 1982 clinical study in rats compared ranitidine and cimetidine exposure in

combination with nitrite. When investigating DNA fragmentation in the rats’ livers, no effect was

observed for cimetidine administered with nitrite, but ranitidine administered with nitrine in a

significant DNA fragmentation.24

76. Investigators at Memorial Sloan Kettering Cancer Center are actively studying

ranitidine to evaluate the extent of the public health implications of these findings. Regarding

ranitidine, one of the investigators commented: “A potential link between NDMA and ranitidine

22 Zeng, et al., Oral intake of ranitidine increases urinary excretion of N-nitrosodimethylamine, 37

CARCINOGENESIS 625-634 (2016). 23 Michaud, et al., Peptic ulcer disease and the risk of bladder cancer in a prospective study of male health professionals, 13 CANCER EPIDEMIOL BIOMARKERS PREV. 2, 250254 (2004). 24 Brambilla, et al., Genotoxic Effects of Drugs: Experimental Findings Concerning Some Chemical

Families of Therapeutic Relevance, 52 CHEMICAL CARCINOGENESIS (1982).


19

is concerning, particularly considering the widespread use of this medication. Given the known

carcinogenic potential of NDMA, this finding may have significant public health implications[.]”25

VII. DEFENDANTS HAD KNOWLEDGE OF THE NDMA DEFECT BUT FAILED TO

WARN OR TEST

77. During the time that Defendants manufactured and sold Zantac in the United States,

the weight of scientific evidence showed that Zantac exposed users to unsafe levels of NDMA.

Defendants failed to disclose this risk to consumers on the drug’s label—or through any other

means—and Defendants failed to report these risks to the FDA.

78. Going back as far as 1981, two years before Zantac entered the market, research

showed elevated rates of NDMA, when properly tested. This was known or should have been

known by Defendants.

79. Defendants concealed the Zantac–NDMA link from consumers in part by not

reporting it to the FDA, which relies on drug manufacturers (or others, such as those who submit

citizen petitions) to bring new information about an approved drug like Zantac to the agency’s

attention.

80. Manufacturers of an approved drug are required by regulation to submit an annual

report to the FDA containing, among other things, new information regarding the drug’s safety

pursuant to 21 C.F.R. § 314.81(b)(2):

The report is required to contain . . . [a] brief summary of significant new information

from the previous year that might affect the safety, effectiveness, or labeling of the drug

product. The report is also required to contain a brief description of actions the applicant

has taken or intends to take as a result of this new information, for example, submit a

labeling supplement, add a warning to the labeling, or initiate a new study.

81. “The manufacturer’s annual report also must contain copies of unpublished reports

and summaries of published reports of new toxicological findings in animal studies and in vitro

25 Valisure Citizen Petition, see https://www.valisure.com/wp-

content/uploads/Valisure-Ranitidine-FDA-Citizen-Petition-v4.12.pdf


https://www.valisure.com/wp-content/uploads/Valisure-Ranitidine-FDA-Citizen-Petition-v4.12.pdf

https://www.valisure.com/wp-content/uploads/Valisure-Ranitidine-FDA-Citizen-Petition-v4.12.pdf

20

studies (e.g., mutagenicity) conducted by, or otherwise obtained by, the [manufacturer] concerning

the ingredients in the drug product.” 21 C.F.R. § 314.81(b)(2)(v).

82. Defendants ignored these regulations and, disregarding the scientific evidence

available to them, did not report to the FDA significant new information affecting the safety or

labeling of Zantac.

83. Defendants never provided the relevant studies to the FDA, nor did they present to

the FDA with a proposed disclosure noting the link between ranitidine and NDMA.

84. In a 1981 study published by GSK, the originator of the ranitidine molecule, the

metabolites of ranitidine in urine were studied using liquid chromatography.26 Many metabolites

were listed, though there is no indication that NDMA was looked for. Plaintiff believe this was

intentional—a gambit by the manufacturer to avoid detecting a carcinogen in their product.

85. Indeed, in that same year, Dr. de Flora published a note in the Lancet discussing the

results of his experiments showing that ranitidine was turning into mutagenic N-nitroso

compounds, of which NDMA is one, in human gastric fluid when accompanied by nitrites – a

substance commonly found in food and in the body. The Defendants were aware of this as GSK

specifically responded to the note and attempted to discredit it. Notwithstanding this legal risk,

GSK intentionally did not test for this alarming cancer risk.

86. By 1987, after numerous studies raised concerns over ranitidine and cancerous

nitroso compounds (discussed previously), GSK published a clinical study specifically

investigating gastric contents in human patients and N-nitroso compounds.27 This study

specifically indicated that there were no elevated levels of N-nitroso compounds (of which NDMA

is one). However, the study was rigged to fail. It used an analytical system called a “nitrogen oxide

assay” for the determination of N-nitrosamines, which was developed for analyzing food and is a

26 Carey, et al., Determination of ranitidine and its metabolites in human urine by reversed-

phase ion-pair high-performance liquid chromatography, 255 J. CHROMATOGRAPHY B:

BIOMEDICAL SCI. & APPL. 1, 161-168 (1981).


21

detection method that indirectly and non-specifically measures N-nitrosamines. Furthermore, in

addition to this approach being less accurate, GSK also removed all gastric samples that contained

ranitidine out of concern that samples with ranitidine would contain “high concentrations of N-

nitroso compounds being recorded.” Without the chemical being present in any sample, any

degradation into NDMA could not, by design, be observed. Again, this test was intentional and

designed to mask any potential cancer risk.

87. In fact, on information and belief, none of the Defendants ever used a mass

spectrometry assay to test for the presence of nitrosamines in any of the studies and trials they did

in connection with their trials associated with the ranitidine NDA. That is because when using

mass spectrometry, it requires heating of up to 130 degrees Celsius, which can result in excessive

amounts of nitrosamines being formed. Had the Defendants used a mass spectrometry assay, it

would have revealed in the finding of large amounts of NDMA, and the FDA would never have

approved Zantac as being safe.

VIII. PLAINTIFF-SPECIFIC ALLEGATIONS

88. Plaintiff began using brand name Zantac in 2014 and continued to use it through

2019. He took the pill five times per week for treatment of heartburn.

89. In October 2019, Plaintiff was diagnosed with bladder cancer.

90. Based on prevailing scientific evidence, exposure to Zantac (and the attendant

NDMA) can cause bladder cancer in humans.

91. Plaintiff’s cancer was caused by ingestion of Zantac.

92. Had any Defendant warned Plaintiff that Zantac could lead to exposure to NDMA

or, in turn, cancer, Plaintiff would not have taken Zantac.

93. Plaintiff did not learn of the link between cancer and Zantac exposure until

September 2019, when he learned that Zantac contained high levels of NDMA in a news article.


22

COUNT I

NEGLIGENCE

94. Defendants, at all pertinent times, had a duty to properly design, manufacture, test,

inspect, package, label, distribute, market, examine, maintain, supply, provide proper warnings

and prepare for use of Zantac.

95. Defendants, at all pertinent times, knew or in the exercise of reasonable care should

have known, that Zantac was of such a nature that they were not properly designed, manufactured,

tested, inspected, packaged, labeled, distributed, marketed, examined, sold, supplied, prepared

and/or provided with the proper warnings, and were unreasonably likely to injure users.

96. Defendants, at all pertinent times, had a duty to exercise reasonable care in the

marketing, advertisement, and sale of the Zantac products. Defendants’ duty of care owed to

consumers and the general public included providing accurate, true, and correct information

concerning the risks of using Zantac and appropriate, complete, and accurate warnings concerning

the potential adverse effects of Zantac and, in particular, its ability to transform into the

carcinogenic compound NDMA.

97. Defendants knew, or should have known in the exercise of reasonable care, of the

hazards and dangers of Zantac and, specifically, the carcinogenic properties of NDMA when

Zantac is ingested, and, in failing to disclose that risk to Plaintiff, acted in conscious disregard for

the safety of Plaintiff.

98. Defendants breached that by failing to comply with state and federal regulations

concerning the study, testing, design, development, manufacture, inspection, production,

advertisement, marketing, promotion, distribution, and/or sale of Zantac, in that Defendants

manufactured and produced defective Zantac which carries the potential to transform into the

carcinogenic compound NDMA; knew or had reason to know of the defects inherent in their


23

products; knew or had reason to know that a user’s or consumer’s use of the products created a

significant risk of harm and unreasonably dangerous side effects; and failed to prevent or adequately

warn of these risks and injuries. Indeed, Defendants deliberately refused to test Zantac products

because they knew that the chemical posed serious health risks to humans.

99. Defendants breached their duty in the sale of Zantac, including, but not limited to,

the following ways:

a. Failing to manufacture, promote, formulate, create, develop, design, sell and/or

distribute Zantac products without thorough and adequate pre- and post-marketing

testing;

b. Negligently or intentionally concealing or failing to disclose the results of trials,

tests and studies of Zantac and the carcinogenic potential of NDMA;

c. Failing to properly study and conduct the necessary tests to determine the adequacy

and effectiveness of Zantac products, and whether they were safe for human

consumption;

d. Failing to inform the ultimate user, Plaintiff, of all serious and relevant risks

associated with Zantac, including its carcinogenic potential;

e. Failing to provide adequate instructions, guidelines, and safety precautions

reasonably foreseeable with use of Zantac products;

f. Failing to warn Plaintiff, consumers, and the general public that the product’s risk

of harm was unreasonable and that there were safer and effective alternative

medications available to Plaintiff and other consumers;

g. Systematically suppressing or downplaying contrary evidence about the risks,

incidence, and prevalence of the side effects of Zantac products;

h. Representing that their Zantac products were safe for their intended use when, in

fact, Defend-ants knew or should have known the products were not safe for their

intended purpose;

i. Declining to make or propose any changes to Zantac products’ labeling or other

promotional materials that would alert consumers and the general public of the risks

of Zantac;


24

j. Advertising, marketing, and recommending the use of the Zantac products, while

concealing and failing to disclose or warn of the dangers known (by Defendants) to

be associated with or caused by the use of or exposure to Zantac;

k. Continuing to disseminate information to their consumers, which indicate or imply

that Defend-ants’ Zantac products are not unsafe for regular consumer use; and

l. Continuing the manufacture and sale of their products with the knowledge that the

products were unreasonably unsafe and dangerous.

100. Despite their ability and means to investigate, study, and test the products and to

provide adequate warnings, Defendants failed to do so. Indeed, Defendants wrongfully concealed

information and further made false and/or misleading statements concerning the safety and use of

Zantac.

101. Defendants, at all pertinent times, knew or in the exercise of reasonable care should

have known Zantac was unreasonably dangerous and defective when put to its reasonably

foreseeable use.

102. As a direct and proximate result of Defendants’ negligence, Plaintiff purchased and

used Zantac products, causing him to develop cancer, incur medical bills, and conscious pain and

suffering.

Wherefore, Plaintiff requests a judgment against Defendants for damages in a sum to

confer jurisdiction upon this Court together with interest on that amount at the legal rate from the

date of judgment until paid, for court costs and for other such relief this Court deems just and

appropriate.

COUNT II

STRICT PRODUCT LIABILITY – DEFECTIVE DESIGN

103. Plaintiff re-alleges and incorporates by reference each and every allegation

contained in the preceding paragraphs as though fully set forth herein.


25

104. Defendants, at all times pertinent, were responsible for designing, developing,

manufacturing, assembling, marketing, testing, packaging, labeling, promoting, selling and

distributing Zantac in the regular course of business.

105. Zantac is defective and unreasonably dangerous to consumers when used in a

manner instructed and provided by Defendants, due to its potential to transform into the

carcinogenic compound NDMA.

106. Zantac is defective and unreasonably dangerous as its utility, the does not outweigh

the danger of developing cancer. Zantac is also defective in its design and/or formulation, as it is not

reasonably fit, suitable or safe for its intended purpose, and the foreseeable risk of developing cancer

exceed the benefits associated with its use.

107. Defendants, at all pertinent times, knew, or should have known in the exercise of

reasonable care, of the hazards and dangers of Zantac and, specifically, the carcinogenic properties

of NDMA when Zantac is ingested, and, in failing to disclose that risk to Plaintiff, acted in

conscious disregard for the safety of Plaintiff.

108. Defendants, at all pertinent times, designed, developed, manufactured, tested,

packaged, promoted, marketed, distributed, labeled and/or sold Zantac in the stream of commerce,

in a defective and unreasonably dangerous condition in ways which include, but are not limited to

the following:

a. Placing inadequate warnings on Zantac when it was first introduced into the stream

of commerce regarding the dangers of NDMA and cancer;

b. Failing to sufficiently test, investigate, or study their Zantac products and,

specifically, the ability for Zantac to transform into the carcinogenic compound

NDMA within the human body;

c. Defendants knew or should have known at the time of marketing Zantac products

that exposure to Zantac could result in cancer and other severe illnesses and injuries;


26

d. Placing a product into the stream of commerce that was defective in design and

formulation, and, consequently, dangerous to an extent beyond that which an

ordinary consumer would contemplate;

e. Placing a product into the stream of commerce, that was unreasonably dangerous

in that it was hazardous and posed a grave risk of cancer and other serious illnesses

when used in a reasonably anticipated manner;

f. Placing a product into the stream of commerce that was unreasonably dangerous

and not reasonably safe when used in a reasonably anticipated or intended manner;

g. Failing to conduct adequate post-marketing surveillance of their Zantac products;

and

h. Failing to employ safer alternative designs and formulations.

109. Plaintiff used and was exposed to Defendants’ Zantac without knowledge of its

dangerous characteristics.

110. At all pertinent times, there were practical and feasible alternative designs, for

example, the Defendants could have added ascorbic acid (Vitamin C) to each dose of Zantac, which

is known to scavenge nitrites and reduce the ability of the body to recombine ranitidine into NDMA.

111. At all pertinent times, the Zantac was substantially in the same condition as when it

left the possession of Defendants.

112. At all pertinent times, Plaintiff used Zantac in a way which was reasonably

foreseeable and normally intended uses by Defendants, as Defendants gave no warning in

opposition.

113. As a direct and proximate result of Defendants’ defective design, Plaintiff

purchased and used Zantac products, causing him to develop cancer, incur medical bills, and

conscious pain and suffering.

114. Defendants’ conduct, as described above, was reckless. Defendants risked the lives

of consumers and users of their products, including Plaintiff, with knowledge of the safety problems


27

associated with Zantac products, and suppressed this knowledge from the general public. Defendants

made conscious decisions not to redesign, warn or inform the unsuspecting public. Defendants’

reckless conduct warrants an award of punitive damages.




appropriate.

COUNT III

STRICT PRODUCT LIABILITY – FAILURE TO WARN



116. Defendants, at all times pertinent, were engaged in the business of designing,

developing, manufacturing, assembling, marketing, testing, packaging, labeling, promoting,

selling and distributing Zantac in the regular course of business.

117. Defendants, at all times pertinent, researched, developed, designed, tested,

manufactured, inspected, labeled, distributed, marketed, promoted, sold, and otherwise released

into the stream of commerce their Zantac products, and in the course of same, directly advertised

or marketed the products to consumers and end users, including Plaintiff, and therefore had a duty

to warn of the risks associated with the use of Zantac products.

118. Defendants had a duty to properly test, develop, design, manufacture, inspect,

package, label, market, promote, sell, distribute, maintain, supply, provide proper warnings, and take

such steps as necessary to ensure their Zantac products did not cause users and consumers to suffer

from unreasonable and dangerous risks. Defendants had a continuing duty to warn Plaintiff of


28

dangers associated with Zantac. Defendants, as a manufacturer, seller, or distributor of

pharmaceutical medication, are held to the knowledge of an expert in the field.

119. At the time of manufacture, Defendants could have provided the warnings or

instructions regarding the full and complete risks of Zantac products because they knew or should

have known of the unreasonable risks of harm associated with the use of and/or exposure to such

products.

120. Defendants knew or should have known that their products created significant risks

of serious bodily harm to consumers, as alleged herein, and Defendants failed to adequately warn

consumers, i.e., the reasonably foreseeable users, of the risks of exposure to their products.

Defendants have wrongfully concealed information concerning the dangerous nature of Zantac

and the potential for ingested Zantac to transform into the carcinogenic NDMA compound, and

further, have made false and/or misleading statements concerning the safety of Zantac products.

121. Defendants’ Zantac products, at all times pertinent, reached the intended

consumers, handlers, and users or other persons coming into contact with these products within

this judicial district and throughout the United States, including Plaintiff, without substantial

change in their defective condition as designed, manufactured, sold, distributed, labeled, and

marketed by Defendants.

122. Defendants failed to warn of the reasonably foreseeable and knowable danger of

Zantac products to transform into the carcinogenic compound NDMA within the human body.

123. Defendants knew or should have known that the minimal warnings disseminated

with their Zantac products were inadequate, failed to communicate adequate in-formation on the

dangers and safe use/exposure, and failed to communicate warnings and instructions that were


29

appropriate and adequate to render the products safe for their ordinary, intended and reasonably

foreseeable uses.

124. This alleged failure to warn is not limited to the information contained on Zantac’s

labeling. The Defendants were able, in accord with federal law, to comply with relevant state law

by disclosing the known risks associated with Zantac through other non-labeling mediums, i.e.,

promotion, advertisements, public service announcements, and/or public information sources. But

the Defendants did not disclose these known risks through any medium.

125. Plaintiff was exposed to Defendants’ Zantac products without knowledge of their

dangerous characteristics.

126. Plaintiff, at all times pertinent, used Defendants’ Zantac products for their intended

or reasonably foreseeable purpose, without knowledge of their dangerous characteristics.

127. Plaintiff could not have reasonably discovered the defects and risks associated with

Zantac products prior to or at the time of Plaintiff consuming Zantac. Plaintiff relied upon the skill,

superior knowledge, and judgment of Defendants to know about and disclose serious health risks

associated with using Defendants’ products.

128. As a direct and proximate result of Defendants’ failure to warn, Plaintiff purchased

and used Zantac products, causing him to develop cancer, incur medical bills, and conscious pain

and suffering.

129. Defendants’ conduct, as described above, was reckless. Defendants risked the lives

of consumers and users of their products, including Plaintiff, with knowledge of the safety problems

associated with Zantac products, and suppressed this knowledge from the general public. Defendants

made conscious decisions not to redesign, warn or inform the unsuspecting public. Defendants’

reckless conduct warrants an award of punitive damages.


30




appropriate.

COUNT IV

BREACH OF EXPRESS WARRANTY



131. Defendants, at all times pertinent, engaged in the business of testing, developing,

designing, manufacturing, marketing, selling, distributing, and promoting Zantac products, which

are defective and unreasonably dangerous to consumers, including Plaintiff, thereby placing

Zantac products into the stream of commerce. These actions were under the ultimate control and

supervision of Defendants.

132. Defendants expressly warranted, through direct-to-consumer marketing,

advertising and labels, that the Zantac products were safe and effective for all reasonably

foreseeable uses. These express representations include incomplete warnings and instructions that

purport, but fail, to include the complete array of risks associated with use of and/or exposure to

Zantac. Defendants knew and/or should have known that the risks expressly included in Zantac

warnings and labels did not and do not accurately or adequately set forth the risks of developing

the serious injuries complained of herein. Nevertheless, Defendants expressly represented that

Zantac products were safe and effective, that they were safe and effective for use by individuals

such as the Plaintiff, and/or that they were safe and effective as consumer medication.

133. Plaintiff saw these advertisements, including television commercials, and believed

the Zantac products were safe and effective.


31

134. The Defendants’ Zantac products did not conform to these express representations

in violation of Rhode Island General Laws §6A-2-313, as well as Rhode Island common law,

because among other things, Zantac products were defective, dangerous, and unfit for use, did not

contain labels representing the true and adequate nature of the risks associated with their use, and

were not merchantable or safe for their intended, ordinary, and foreseeable use and purpose.

Specifically, Defendants breached the warranties in the following ways:

a. Representing through their labeling, advertising, and marketing materials that Zantac

products were safe, and intentionally withheld and concealed information about the

risks of serious injury associated with use of Zantac and by expressly limiting the

risks associated with use within their warnings and labels; and

b. Representing that Zantac products were safe for use and intentionally concealed

information that demonstrated that Zantac, by transforming into NDMA once

ingested, had carcinogenic properties.

135. As a direct and proximate result of Defendants’ breach of express warranty,

Plaintiff purchased and used Zantac products, causing him to develop cancer, incur medical bills,

and conscious pain and suffering.




appropriate.

COUNT V

BREACH OF IMPLIED WARRANTY






32


Zantac products into the stream of commerce. These actions were under the ultimate control and

supervision of Defendants.

138. Defendants, at all times pertinent, impliedly warranted to their consumers,

including Plaintiff, that Zantac products were of merchantable quality and safe and fit for the use

for which they were intended; specifically, as consumer medication.

139. Defendants, at all times pertinent, were aware that consumers and users of their

products, including Plaintiff, would use Zantac products as marketed by Defendants.

140. The Zantac products were defective in design and manufacture and were therefore

not fit for their intended uses, and, were not designed, manufactured, or sold in accordance with

industry standards. The Zantac products were not fit for the common, ordinary and intended uses.

Therefore, Defendants breached the implied warranty of merchantability as well as the implied

warrant of fitness for a particular purpose as stated in Rhode Island General Laws § 6A-2-314, and

Rhode Island common law.

141. When the Zantac products entered the stream of commerce, they were unsafe for

their intended use, not of merchantable quality as warranted by Defendants.

142. In reliance upon Defendants’ implied warranty, Plaintiff used Zantac as instructed

and labeled and in the foreseeable manner intended, recommended, promoted, and marketed by

Defendants.

143. As a direct and proximate result of Defendants’ breach of implied warranty,

Plaintiff purchased and used Zantac products, causing him to develop cancer, incur medical bills,

and conscious pain and suffering.


33




appropriate.

COUNT VI

FRAUD






Zantac products into the stream of commerce.

146. Defendants knew or should have known that Plaintiff, based off Defendants’

representations that the Zantac medications were safe and effective as consumer medication, would

purchase and ingest the Zantac products.

147. Defendants intentionally, willfully and/or recklessly concealed information

concerning the dangerous nature of Zantac and the potential for ingested Zantac to transform into

the carcinogenic NDMA compound, and further, made false and/or misleading statements

concerning the safety of Zantac products.

148. Defendants misrepresented or concealed material facts concerning the Zantac

products to consumers, including Plaintiff, with knowledge of the falsity of their

misrepresentations.

149. Defendants knew or should have known that their products created significant risks

of serious bodily harm to consumers, as alleged herein, and Defendants failed to adequately warn


34

consumers, i.e., the reasonably foreseeable users, of the risks of exposure to their products, even

though those risks were not readily apparent to ordinary users.

150. The misrepresentations and concealments by Defendants concerning the Zantac

products include, but are not limited to:

a. Knowingly misrepresenting to Plaintiff, and the general public, through the

advertisements and marketing described above, that the Zantac products are safe

when used as directed;

b. Intentionally failing to disclose that when ingested, Zantac can transform into the

carcinogenic NDMA compound;

c. Intentionally failing to include adequate warnings with the Zantac products

regarding the potential and actual risk of the drug, as well as the nature, scope and

severity of any serious injuries, including cancer; and

d. Knowingly concealing the Zantac products’ carcinogenic nature and falsely

marketing, labeling and advertising the products as safe for public consumption and

use.

151. Plaintiff was induced to, and relied upon, Defendants’ misrepresentations of

material fact, and purchased and ingested the Zantac Products.

152. As a direct and proximate result of Defendants’ fraudulent misrepresentation and

concealment of material fact, Plaintiff purchased and used Zantac products, causing him to develop

cancer, incur medical bills, and conscious pain and suffering.




appropriate.

COUNT VII

NEGLIGENT MISREPRESENTATION


35



154. Defendants had a duty to accurately and truthfully represent to the medical and

healthcare community, Plaintiff and the public, that the Zantac products were tested and found to

be safe and effective. Defendants’ representations, however, were false.

155. Defendants failed to exercise ordinary care in the representations concerning the

Zantac products while they were involved in their manufacture, sale, testing, quality control and

assurance, and distribution into interstate commerce, because they negligently misrepresented the

Zantac products high risk of unreasonable, dangerous and adverse side effects.

156. Defendants breached their duty in representing that the Zantac products have no

serious and life-threatening side effects, and were safe for all their intended uses.

157. As a foreseeable, direct and proximate result of this negligent misrepresentation,

Defendants had reason to know that the Zantac products had been insufficiently tested, they lacked

adequate and accurate warnings, and they created a higher and/or higher than acceptable risk of

adverse effects, like cancer.

158. At all pertinent times, the misrepresentations, omissions and concealments

concerning the Zantac products made by Defendants include, but are not limited to:

a. Failing to disclose to Plaintiff, and those similarly situated, through adequate

warnings, representations, labeling or otherwise, that the Zantac products were

inherently dangerous and carcinogenic in nature, posing serious health risk to

consumers;

b. Failing to disclose to Plaintiff, and those similarly situated, through adequate

warnings, representations, labeling or otherwise, the material fact that use of the

Products increased the risk of cancer; and

c. Falsely marketing, advertising, labeling and selling the Zantac products as safe and

effective for public consumption, despite knowledge of its carcinogenic nature.


36

159. Defendants, at all times pertinent, failed to exercise reasonable care in ascertaining

or sharing information regarding the Zantac products’ safe use, failed to disclose facts indicate that

Zantac products were inherently dangerous and carcinogenic in nature, and otherwise failed to

exercise reasonable care in communicating this information to Plaintiff.

160. Plaintiff, at all times pertinent, was neither aware of the falsity of the foregoing

misrepresentations, nor that the material facts concerning the Zantac products had been concealed

or omitted. In reasonable reliance on Defendants’ omissions and/or misrepresentations, Plaintiff

was induced to and did purchase and use the Zantac products. If Defendants had disclosed true and

accurate material facts concerning the risks of the Zantac products, in particular the risk of

developing cancer, the Plaintiff would not have purchased and used the Zantac products.

161. Plaintiff’s reliance upon Defendants misrepresentations and omissions was justified

and reasonable because, among other reasons, those misrepresentations and omissions were made

by individuals and entities who were in a position to know the material facts concerning the Zantac

products and the association between the Zantac products and cancer. Plaintiff was not in a position

to know these material facts, and Defendants failed to warn or otherwise provide notice as to those

risks, thereby inducing Plaintiff to use the Zantac products.

162. As a direct and proximate result of Defendants’ negligent misrepresentation and

concealment of material fact, Plaintiff purchased and used Zantac products, causing him to develop

cancer, incur medical bills, and conscious pain and suffering.




appropriate.


37

COUNT VIII

PUNITIVE DAMAGES

163. Plaintiff incorporates by reference each preceding and succeeding paragraph as

though set forth fully at length therein. Plaintiff pleads all Counts of this Complaint in the broadest

sense, pursuant to all laws that may apply pursuant to choice of law principles including the law

of Plaintiff’s resident State.

164. Defendants sold the Zantac products to Plaintiff and other consumers throughout

the United States without doing adequate testing to ensure that the Zantac products were

reasonably safe for their intended use.

165. Defendants sold the Zantac products to Plaintiff and other consumers throughout

the United States in spite of their knowledge that the Zantac products cause the problems

heretofore set forth in this Complaint, thereby causing the severe and debilitating injuries suffered

by the Plaintiff.

166. At all times pertinent hereto, Defendants knew or should have known that the

Zantac products were inherently dangerous with respect risk of cancer, loss of life’s enjoyment,

an effort to cure the conditions proximately related to the use of the product, as well as other severe

and personal injuries which are permanent and lasting in nature.

167. At all times material hereto, Defendants attempted to misrepresent and did

misrepresent facts concerning the safety of the Zantac products, including but not limited to

information regarding the increased risk of developing cancer.

168. Defendants’ misrepresentations included knowingly withholding material

information from the consumers, including Plaintiff, concerning the safety and efficacy of the

Zantac products.


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169. At all times material hereto, Defendants knew and intentionally and/or recklessly

disregarded the fact that the Zantac products cause debilitating and potentially lethal side effects

with greater frequency than safer alternative products.

170. At all times material hereto, Defendants knew and intentionally and/or recklessly

disregarded the fact that the Zantac products cause debilitating and potentially lethal side effects

with greater frequency than safer alternative products and recklessly failed to advise the public of

the same.

171. At all times material hereto, Defendants intentionally misstated and misrepresented

data and continue to misrepresent data so as to minimize the true and accurate risk of injuries and

complications caused by the Zantac products.

172. Notwithstanding the foregoing, Defendants continue to aggressively market the

Zantac products to consumers, without disclosing the true risk of side effects.

173. Defendants knew that the Zantac products were defective and of an unreasonably

dangerous nature, but continued to manufacture, produce, assemble, market, distribute, and sell

the Zantac products so as to maximize sales and profits at the expense of the health and safety of

the Public, including Plaintiff, in conscious and/or reckless disregard of the foreseeable harm

caused by the Zantac products.

174. Defendants continue to intentionally conceal and/or recklessly and/or grossly

negligently fail to disclose to the public, including Plaintiff, the serious side effects of the Zantac

products in order to ensure continued and increased sales.

175. Defendants’ intentional, reckless and/or grossly negligent failure to disclose

information deprived Plaintiff of necessary information to enable her to weigh the true risks of

using the Zantac products against their benefits.


39

176. As a direct and proximate result of the foregoing acts and omissions, Plaintiff has

required and will require health care and services, and have incurred medical, health care,

incidental, and related expenses. Plaintiff is informed and believes and further alleges that

Plaintiffs and other members of the public will in the future be required to obtain further medical

care and/or hospital care and medical services.

177. Defendants have engaged in conduct entitling Plaintiff to an award of punitive

damages pursuant Common Law principles and the statutory provisions of the Plaintiff’s

respective home state and Defendants’ home states.

178. Defendants’ conduct as described herein shows willful misconduct, malice, fraud,

wantonness, oppression, or that entire want of care which raises the presumption of conscious

indifference to consequences, thereby justifying an award of punitive damages.




appropriate.

TAG-ALONG ACTION

179. This is a potential tag-along action and in accordance with 28 U.S.C. §14-7, it

should be transferred to the United States District Court for Florida Southern District of Florida

for inclusion in In Re: Zantac (Ranitidine) Products Liability Litigation, MDL 2924 (Hon. Robin

L. Rosenburg).

RELIEF REQUESTED

WHEREFORE Plaintiff prays for judgment against Defendants and, as appropriate to each

cause of action alleged and as appropriate to the standing of Mr. Lane, as follows:


40

1. economic and non-economic damages in an amount as provided by law and to be supported

by evidence at trial;

2. for compensatory damages according to proof;

3. for declaratory judgment that Defendants are liable to Plaintiff for all evaluative,

monitoring, diagnostic, preventative, and corrective medical, surgical, and incidental expenses,

costs, and losses caused by Defendants’ wrongdoing to Mr. Lane;

4. for disgorgement of profits;

5. for an award of attorneys’ fees and costs;

6. for prejudgment interest and the costs of suit;

7. punitive or exemplary damages according to proof; and

8. for such other and further relief as this Court may deem just and proper.

DEMAND FOR JURY TRIAL

Plaintiff hereby demands a trial by jury as to all claims in this action.

Dated: February 28, 2020 RESPECTFULLY SUBMITTED,

/s/ Vincent Greene

Motley Rice LLC

55 Cedar Street, Suite 100

Providence, RI 02903

(401)457-7730

(401)457-7708

[email protected]

Carmen S. Scott*

Motley Rice LLC

28 Bridgeside Blvd.

Mt. Pleasant, SC 29464

(843) 216-9160

(843) 216-9450 (Fax)

[email protected]

* Application for pro hac vice pending

Attorneys for Plaintiffs


mailto:[email protected]

mailto:[email protected]

UNITED STATES DISTRICT COURT MICHAEL LANE, Plaintiff ......Feb 28, 2020 · of individuals to treat...

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